Breakthrough Fda Status: New Dmd Drug Del-Zota Shows Promise for Rare Muscle Disease Treatment

Del-zota for DMD awarded FDA breakthrough therapy designation

The U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to delpacibart zotadirsen, known as del-zota, as a treatment for people with Duchenne muscular dystrophy (DMD) amenable to exon 44 skipping. This designation is intended to speed the development and review of therapies for serious conditions when early clinical evidence is suggestive of a substantial improvement over available alternatives. Avidity Biosciences, …

Avidity Biosciences Receives FDA Breakthrough Therapy Designation for Delpacibart Zotadirsen (del-zota) for the Treatment of DMD in People with Mutations Amenable to Exon 44 Skipping

- On track for planned BLA submission for del-zota at year end 2025 -